EU Council Sets Stance on Pharma Reform Package

The European Council has adopted its position on the EU's Pharma Package, a major pharmaceutical reform aiming to ensure fairer access to medicines, improve industry competitiveness, and boost supply security.

Key proposals include:

• 8 years of regulatory data protection for innovative drugs

• 1 year of market exclusivity, extendable to 2 if key goals are met

• Mandatory supply obligations for drugmakers

• Transferable exclusivity vouchers allowed in the 5th year if EU sales stay below €490M over 4 years

• Expanded ‘Bolar exemption’ to speed up market entry of generics and biosimilars

The package also includes stricter environmental rules. Negotiations with the European Parliament will follow to finalize the legislation.

The reform is designed to make EU medicines safer, more accessible, and more environmentally sustainable.

10-06-2025